UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035604 |
|---|---|
| Receipt number | R000040568 |
| Scientific Title | Development of the Hiesho improvement support model to promote adherence among pregnant women-development of educational material using digital contents to improve nursing knowledge. |
| Date of disclosure of the study information | 2019/01/21 |
| Last modified on | 2023/07/28 13:37:14 |
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Basic information
Public title
Development of the Hiesho improvement support model to promote adherence among pregnant women-development of educational material using digital contents to improve nursing knowledge.
Acronym
Development of the Hiesho improvement support model-development of educational material for nurses.
Scientific Title
Development of the Hiesho improvement support model to promote adherence among pregnant women-development of educational material using digital contents to improve nursing knowledge.
Scientific Title:Acronym
Development of the Hiesho improvement support model-development of educational material for nurses.
Region
| Japan |
Condition
Condition
Nurses working at the maternity or outpatient ward in the hospital or medical clinic, who consented to participate in the study.
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing educational material for nurses based on evidence, using digital contents about the Hiesho of pregnant women, and evaluating the effectiveness of the material in improving nurses' knowledge of Hiesho and awareness regarding Hiesho care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
In the intervention group, knowledge of Hiesho of the nurse working at maternity ward is significantly higher compared to the control group (p<0.05) after intervention.
Key secondary outcomes
Following intervention, nurses in the intervention group, who worked in the maternity ward, exhibited a significant improvement in their knowledge of Hiesho as compared to those in the control group (p<0.05).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention period: 2 weeks
Description of intervention:
Intervention group: 1) 1 week studying using digital contents on knowledge of Hiesho (Part 1: Theory) 2) 1 week studying using digital contents on improving Hiesho care (Part 2: Practice)
Interventions/Control_2
Control group: Studying using a brochure (1st week: diagnosis of Hiesho, 2nd week: Program for improving Hiesho care)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Nurses working at the maternity or outpatient ward in the hospital or medical clinic, who consented to participate in the study.
Key exclusion criteria
Participants who do not meet the inclusion criteria.
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Sachiyo |
| Middle name | |
| Last name | Nakamura |
Organization
Yokohama City University
Division name
School of Medical Nursing Course
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanazawa 236-0004, Japan
TEL
045-878-2786
nakamura@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Sachiyo |
| Middle name | |
| Last name | Nakamura |
Organization
Yokohama City University
Division name
School of Medical Nursing Course
Zip code
2360004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanazawa 236-0004, Japan
TEL
045-878-2786
Homepage URL
nakamura@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sport, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanazawa 236-0004, Japan
Tel
045-370-7627
rinri@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
130
Results
The knowledge of hiesho was significantly higher in the intervention group than in the control group (p <0.01, 95% CI 1.24-2.94, effect size 0.85).
The recognition of the importance for hiesho care during pregnancy was that the intervention group scored significantly higher than the control group (p <0.01, 95% CI 1.06-5.15, effect size 0.54 Medium).
Results date posted
| 2021 | Year | 01 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Nurses working in a hospital- or clinic-based obstetric wards or outpatient facilities in Japan
Participant flow
After approval of the research cooperation, the intervention group will study hiesho-education program for nurses conducted using a web-based approach for two weeks. The control group only distributes pamphlets. The evaluation was conducted three times, immediately before the implementation, one week after the end of Web learning, and four weeks after the end of Web learning.
Adverse events
None
Outcome measures
Knowledge of hiesho: 4 choices 20 items
Recognition of importance regarding hiesho: 8 items
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040568
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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